Amgen gets FDA nod for Evenity
The Food and Drug Administration has approved Amgen’s Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk of breaking a bone (fracture). These are women with a history of osteoporotic fracture or multiple risk factors for fracture, or those who have failed or are intolerant to other osteoporosis therapies.
More than 10 million people in the United States have osteoporosis, which is most common in women who have gone through menopause. People with osteoporosis have weakened bones that are more likely to fracture.
"Today's approval provides women with postmenopausal osteoporosis who are at high risk of fracture with a new treatment that will reduce this risk," the director of the Center for Drug Evaluation and Research's division of bone, reproductive and urologic products, Hylton Joffe said. "But Evenity may increase the risk of heart attack, stroke and cardiovascular death so it's important to carefully select patients for this therapy, which includes avoiding use in patients who have had a heart attack or stroke within the previous year."
Evenity is a monoclonal antibody that blocks the effects of the protein sclerostin and works mainly by increasing new bone formation.
One dose of Evenity consists of two injections, one immediately following the other, given once a month by a health care professional. The bone forming the effect of Evenity wanes after 12 doses so more than 12 doses should not be used. If osteoporosis therapy is needed after the 12 doses, patients should begin an osteoporosis treatment that reduces bone breakdown.
More than 10 million people in the United States have osteoporosis, which is most common in women who have gone through menopause. People with osteoporosis have weakened bones that are more likely to fracture.
"Today's approval provides women with postmenopausal osteoporosis who are at high risk of fracture with a new treatment that will reduce this risk," the director of the Center for Drug Evaluation and Research's division of bone, reproductive and urologic products, Hylton Joffe said. "But Evenity may increase the risk of heart attack, stroke and cardiovascular death so it's important to carefully select patients for this therapy, which includes avoiding use in patients who have had a heart attack or stroke within the previous year."
Evenity is a monoclonal antibody that blocks the effects of the protein sclerostin and works mainly by increasing new bone formation.
One dose of Evenity consists of two injections, one immediately following the other, given once a month by a health care professional. The bone forming the effect of Evenity wanes after 12 doses so more than 12 doses should not be used. If osteoporosis therapy is needed after the 12 doses, patients should begin an osteoporosis treatment that reduces bone breakdown.